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Old 01-11-2017, 08:14 AM   #1 (permalink)
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Thumbs up ITA Update 1/10/17

ITA Member Update - January, 2017

Political life in Nation's Capital is anything but normal with Team Trump rewriting the rulebook on a daily basis. Given that this industry desperately wants to see a change, we are counting on this new rulebook to play to our advantage.

The first positive sign has been the lack of activity at the FDA. As of the first of January, there is still no signal that the two proposed rules (amendments to the performance standard and the restricted device designation/under 18 ban) will be promulgated before Mr. Trump is sworn in as the 45th President of the United States. This is supported by the fact that there is no indication that the rules have gone to the Office of Management and Budget (OMB) for approval. OMB review is usually the last critical step before the rules are finalized. While nothing is certain, this is encouraging. After January 20th, it is unlikely these rules will be a priority for the incoming administration or the new leadership at the FDA.

For those who use Google Alerts to track news, you probably noticed the heightened negative press regarding indoor tanning, melanoma and calls for age restrictions during December. It seems clear to me all the bad press was generated by our detractors in an effort to put last minute pressure on the FDA to issue the rules and ban teen tanning before Trump takes office. The fact that the FDA has not acted is another positive sign.

With regard to repeal of the Affordable Care Act (ACA) and the direction of health policy at the FDA, there is more good news coming in with the Trump Administration. The next Secretary of Health and Human Services (HHS), Rep. Tom Price (R-GA), is a staunch conservative and identifies as a member of the Tea Party caucus. As Member of Congress, Rep. Price was a vocal critic of the ACA and will be a willing leader in carrying out the Trump campaign's promise to repeal the law.

Although the FDA is under the Department of Agriculture, HHS sets the tone for healthcare policy throughout the government. Having a HHS Secretary with Rep. Price's approach to government will surely shepherd in a welcome change.

For the repeal of the tan tax, the only hurdle may be the timing. There were published news reports in December citing unnamed sources indicating that Congressional Republicans are considering holding off on repealing some of ObamaCare's taxes. This doesn't mean the Tan Tax won't be repealed, only that the Congress may tackle the ACA taxes as a part of a larger tax reform bill later in the year.

This week, President-elect Trump publicly supported Senator Rand Paul's (R-KY) call to vote on a replacement plan for Obamacare at the same time as the vote to repeal the mammoth law. The challenge here is that there is no agreement on the replacement and it is not clear when there will be.

Stay tuned, I am cautiously optimistic and look forward to the next couple of months.

Over the past year, the ITA has worked hard to make certain the business interests of the entire industry have been represented and protected in all our interactions and meetings with policy-makers in Washington. Our work with the FDA on the two proposed rules is at a critical juncture. Please renew your membership in the association for 2017. We need the support of the entire industry to continue this important work.

Thanks,
John Overstreet, Executive Director
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